Behind the FDA Approval of Daratumumab Plus VRd in Newly Diganosed Myeloma

On July 30, 2024, the FDA approved the daratumumab and hyaluronidase-fihj regimen (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (D-VRd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

A minimal residual disease (MRD) analysis of the PERSEUS study (NCT03710603) compared 2 treatment regimens in this patient population. Patients received either D-VRd or VRd. Both treatments were followed by maintenance therapy.

The study found that D-VRd led to significantly deeper responses and higher rates of MRD negativity compared to VRd. These benefits were observed both during and after the initial treatment period. Patients who achieved MRD negativity with D-VRd were more likely to maintain this status for a longer period.

The improved response rates and deeper remission achieved with D-VRd translated to a longer period without disease progression compared to VRd. These results suggest that D-VRd is a superior treatment option for patients with newly diagnosed multiple myeloma.

Here, Paula Rodríguez Otero, MD, PhD, University Clinic of Navarra, Pamplona, Spain, discussed the findings from this analysis.

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0:05 | D-VRd induction consolidation and DR maintenance increase the proportion of patients that achieved MRD negativity, both at 10^-5 and also at 10^-6 as compared to VRd followed by lenalidomide alone. So, we do see a clear deepening of the responses throughout the treatment. And more importantly during the maintenance phase and this deepening of the response is higher in the daratumumab-containing arm as compared to the VRd plus [lenalidomide] arm. We also see a higher proportion of patients that achieved sustained MRD negativity, both lasting for 12 months or longer and also 18 months or longer, both 10^-5 and 10^-6, and this is higher in the daratumumab-containing arm.

0:53 | In the 2 scenarios, for MRD rates and sustained MRD negativity, if we analyze the subgroup a data, we do see a PFS consistent benefit in favor of daratumumab-VRD across all different subgroup of patients, including older age, ISS3, or high-risk disease.